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YMA, the principal investigator of the original trial, conceived and designed the study, interpreted data and drafted the manuscript.
MF carried out the original clinical trial, conceived of the design for the observational study, and participated in the drafting and revisions of the manuscript.
The presented study is a multi-centre, randomised, controlled, 3-armed clinical trial conceived as parallel-group design with blinded observation of the primary endpoint via telephone interview.
SKL is the principal investigator of the trial, conceived of the research proposal and study design, obtained the research grant, analysed the data, and participated in preparation of the manuscript.
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This investigator initiated trial was conceived by the West Midlands Research Collaborative, a trainee led surgical research group who designed, disseminated, and managed the trial in conjunction with the Primary Care Clinical Research and Trials Unit and the Birmingham Clinical Trials Unit at the University of Birmingham.
The first trial was conceived as a 2 × 3 factorial design with three levels of fish meal replacement (FMR; 50, 75 and 100% of dietary protein) by soy protein concentrate (SPC), and two levels of mannan oligosaccharide (MOS) supplementation (0 or 0.3% of the diet).
As a barrister, Hale represented a variety of Royalist figures during the prelude and duration of the English Civil War, including Thomas Wentworth and William Laud; it has been hypothesised that Hale was to represent Charles I at his state trial, and conceived the defence Charles used.
When this trial was conceived, it was unknown whether the sparse blood sampling achievable in children would be sufficient to show any treatment differences.
HS trial management, conceived health service utilisation data analysis protocol.
The trial was conceived by KSK, BWM and the Leonardo project team.
The TREAT-ME1 trial was conceived based on the previously performed preclinical studies.
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